Last updated on July 2019

PREservation Versus Thermal Ablation

Brief description of study

This study will be looking at the effect of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).

Detailed Study Description

Full venous duplex ultrasonography was performed using B-K Medical REF ZV0071 ultrasound scan. Cognizant of the negative consequences of standing and sitting for long periods of time (e.g. venous hypertension, venous reflux), we scheduled investigations for early morning, thus ensuring examination of the physiological status of the venous system in each patient. Ultrasound examinations of reflux at the saphenofemoral junction (SFJ) were performed using the Valsalva maneuver. Ultrasound examination of GSV reflux was performed by manually compressing the calf followed by sudden release. Reverse flow that lasted more than 0.5 seconds was considered pathological. Preoperative venous duplex mapping was done in the upright position. Further measurements of the GSV diameter 15 cm below the SFJ level were conducted to describe the severity of varicose veins more accurately.

The diameter of GSV at the 15-cm below the SFJ level was the main criterion to identify two groups of patients. Those with the GSV diameter 6 mm were treated with ASVAL. If the diameter of GSV was > 6 mm, EVLA with concomitant phlebectomy was performed.

All surgical procedures were accomplished by the same surgeon, using tumescent local anesthesia (i.e. 0,1% lidocaine and sodium bicarbonate solution without epinephrine).The EVLA was done under duplex guidance with a 1560-nm diode laser using bare fibres via a Seldinger wire technique. The GSV was cannulated at the lowest point of the reflux. The laser fiber was advanced below the SFJ at the level of v. epigastrica sup. after which the GSV was ablated during gradual withdrawal of the fibre. The 15W laser power was delivered in a continuous pull back traction. The average applied linear endovenous energy dose (LEED) was 75,3, CD=9,2 J/cm.

Peripheral side branches were removed by multiple stab avulsions using Vrady hook in both groups. After the treatment, the leg was wrapped in sterile absorbent bandages, and compression stockings class II (23-32 mm Hg) were put on and recommended to wear for two weeks. All patients were discharged on the day of the treatment and were invited to a follow-up duplex ultrasonography (DUS) on the 1st post-operative day and 2 years after the operation (patients were contacted by phone). DUS at the 2 years follow-up visits was carried out by an independent specialist who was not involved in the initial treatment of the patients. To report clinical recurrence after EVLA we have used Groupe d' valuation des Lasers et de l'chographie Vasculaire (GELEV) score.

The objectives of the study were the following: 1) to determine the 2 years clinical and functional outcomes while taking into account the severity of the disease (as measured by VCSS) 11 and the degree to which patients were affected by it; 2) to establish the 2 years clinical recurrence-free rate according to the classification of recurrent varicose veins after treatment (PREVAIT). PREVAIT defined as the presence of any new visible or palpable varicosities on the studied leg that had been noticed through the clinical examination. The criterion of a recurrent varicose vein was a visible or palpable varicosity with a diameter of more than 3 mm.

Clinical Study Identifier: NCT04034329

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